FDA 510(k)

肝脂肪超声定量系统，The FattaLab (FL-CC M1, FL-CC M1_Pro)

K号: K253221 · 2026-02-06

申请人Eieling Technology (Shenzhen) Limited

决定日期2026-02-06

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) is the device name listed in this FDA 510(k) record. The listed applicant is Eieling Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K253221. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)?

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is Eieling Technology (Shenzhen) Limited. The 510(k) number is K253221.

When did Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) receive FDA 510(k) clearance?

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) received FDA 510(k) clearance on 2026-02-06, under 510(k) number K253221.

Who is the listed applicant for Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)?

The FDA 510(k) record lists Eieling Technology (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)?

The FDA product code for Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) is IYO.

列明Eieling Technology (Shenzhen) Limited为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242496便携式肝脏弹性超声诊断系统（Liverscan C）

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